ZGynO_CINIII: Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04753073

Collaborator

(none)

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the prospective, unicenter proof-of-principle study is to investigate the anti-neoplastic effectiveness of NIPP against CIN III lesions.

The aim of this project is to evaluate the potential of a previous NIPP treatment to significantly reduce the invasiveness of the LEEP excision.
Another aim of this study is to investigate cellular / molecular effects of NIPP following the in-vivo treatment of the cervix using molecular biological methods. For this purpose, tissue treated with plasma is taken after defined periods of time by mini biopsy and examined using molecular biological, histological and microscopic methods.

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia III	Procedure: Non-invasive physical plasma	N/A

Detailed Description

Cervical intraepithelial neoplasms (CIN), classified into severity levels CIN I to III, can be precursors to cervical cancer (CC), the world's third most common cancer in women (270,000 deaths / year), which radical therapies are often associated with lifelong severe physical and emotional stress. Cross-sectional studies found a prevalence for CIN of 62 per 1,000 women and incidences of 1.2 (CIN I), 0.8 (CIN II) and 0.7 (CIN III) per 1,000 women per year (highest incidence of CIN between 20 and 24 years) age). The standard therapy for the treatment of CIN III by LEEP excision is associated with an increase in mortality of 17%. CIN III, in particular, is associated with a significant decline in quality of life, psychological well-being and sexual health, although on average only about 12% of CIN III lesions progress to invasive CC. The resulting over-treatment (in around 8-9 out of 10 patients) with invasive procedures is a serious problem for affected women, health care providers and the health economy.

The NIPP treatment is a tissue-sparing, pain-free, easy to carry out and outpatient treatment method without anesthesia and hospitalization. A non-randomized, one-arm feasibility study at the Department of Women's Health (649 / 2017BO1) already showed the effectiveness of a NIPP treatment.

Clinical implications for CIN III:

A previous NIPP treatment should significantly reduce the invasiveness of the LEEP excision.
If the oncological safety of NIPP treatment is comparable (histological complete remission of CIN III), NIPP is to be established as a safe alternative to LEEP excision in the future.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NIPP Treatment of the NIPP group with physical low-temperature plasma, subsequently within 8 weeks LEEP-Exzision	Procedure: Non-invasive physical plasma Treatment with non invasive physical low-temperature plasma
No Intervention: Controll LEEP-Exzision

Arm

Intervention/Treatment

Experimental: NIPP

Treatment of the NIPP group with physical low-temperature plasma, subsequently within 8 weeks LEEP-Exzision

Procedure: Non-invasive physical plasma

Treatment with non invasive physical low-temperature plasma

No Intervention: Controll

LEEP-Exzision

Outcome Measures

Primary Outcome Measures

Rate of histological complete remission [8 Weeks]
Rate of histological complete remission of the CIN III at the time of the LEEP excision

Secondary Outcome Measures

Rate of partial histological remission [8 Weeks]
Rate of partial histological remission of the CIN I / II
Rate of decreased HPV viral load [8 Weeks]
Rate of decreased HPV viral load in tissues
Pain and quality of life [8 Weeks]
Pain and quality of life (Freiburg index for patient satisfaction) Pain assessment i) previous to, ii) during, iii) 4 h after, iv) 2 days after, v) 1 week after NIPP treatment, min/max values: 0 - 10, higher scores mean worse outcome Satisfaction assessment, min/max values: 1-6, higher scores mean worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
Histologically confirmed CIN III
Clearly visible transformation zone of the portio and margins of the lesions according to T1 / T2
signed written consent

Exclusion Criteria:

Not fully visible transformation zone
Indication of an invasive disease
Serious cardiovascular diseases
Patients who only want to undergo a LEEP excision

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Tuebingen, Department of Women's Health	Tuebingen		Germany	72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator: Martin Weiss, Dr. med.q, Department of Women's Health, University Hospital Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT04753073

Other Study ID Numbers:

ZGynO_CIN_III

First Posted:

Feb 12, 2021

Last Update Posted:

Jun 23, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Carcinoma in Situ

Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of Jun 23, 2021